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Patrick A. Jordan 3112 Ridgestone Parkway
p.l.jordan1999@gmail.com Durham, NC 27712
(C) (919)257-8983
Professional Experience
 Therapeutic experience in IVD, Oncology, Hematology, Orthopedics, GI, Cardiology, Melanoma,
ENT, Multiple Sclerosis, and ADHD
 Extensive knowledge of FDA regulations, ICH guidelines, GLPs,GCPs, and SOPs
 Monitoring experience of national and international sites for PSSVs, SIVs, IMVs,and COVs
 Ability to identify issues and resolve appropriately
 Experience in multiple EDC systems and platforms
Professional Experience
Clinical Operations Health Decisions 01/2016-07/2016
CRA
Therapeutic Areas: Women’s Health – Contraceptive device, IVD, and Neonatalpreterm birth
Phases: III
● Responsible forCRA dutiesforcommerciallyfundedprotocols –medical device andIVD(invitro
diagnosticdevice)involvingnational sites
● Perform monitoring visits - PSSV,SIV, IMV, and COV
● Ensure the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines, and
protocols
● Ensure that the rights, safety, and well-being of clinical trial subjects are maintained
● Collaborate with the Core Project Team and site staff to drive subject recruitment
● Prepare all monitoring documentation/reports for assigned protocols as required
● Establish and maintain effective contact with internal and external personnel (primary point of contact
for site staff)
● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance
Clinical Operations Rho, Inc. 10/2014-09/2015
CRA I
Therapeutic Areas: ENT,Multiple Sclerosis, Rheumatoid Arthritis, and ADHD (Pediatrics)
Phases: III
● Responsible forCRA dutiesforfederallyandcommerciallyfundedprotocolsinvolvingnational and
international sites
● Performed monitoring visits - SQV,SIV, IMV, and COV
● Ensured the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines,
and protocols
● Ensured that the rights, safety,and well-being of clinical trial subjects are maintained
● Collaborated with the Core Project Team and site staff to drive subject recruitment
● Prepared all monitoring documentation/reports for assigned protocols as required
● Established and maintained effective contact with internal and external personnel (primary point of
contact for site staff)
● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance
DCRI Duke University Medical Center 03/2014-07/2014
CRA II
Therapeutic Areas: Antibacterialresistance
Phases: I-II
● Lead onPSSVsforthree (3) clinical trialsinvolving104 potential worldwide sites
● Performed site feasibility and site selection documentation for ARLG protocols
● Maintained all ARLGSite Trackers for all active and upcoming ARLG protocols
● Primary point of contact for sites and vendors
● Wrote guidelines and SOPs for ARLG protocols and international sites
Ockham Contractor at Quintiles 12/2013-03/2014
CTA
Therapeutic Areas: Gastrointestinal disorders
Phases: III
● Lead CTA team fortwo (2) Purdue studiesas well ascontrollingaccessforall electronicsystems(EDC,
CTMS, ordering,materials,andIP) forbothinternal andexternal customers
● Updated and prepared the compliance, performance,and timeline matrix
● Prepared,distributed, filed, and archived clinical documentation
● Performed QA/QC review of study files
● Distributed Clinical Trial Supplies to sites
● Controlled and maintained access for all electronic systems for internal and external customers
Pinnacle Technology Contractor at BectonDickinson 07/2013-08/2013
CRA II (Short Contract)
Therapeutic Areas: Women’s Health (OB/GYN)
Phases: I-II
● Successfullycompletedcontractedobjective inhalf the time allotted
● Performed CRA responsibilities for 3 protocols and multiple sites
● Prepared all monitoring documentation/reports for assigned protocols as required
● Performed monitoring visits such as site evaluation, SIV, IMV, and COV
● Facilitated the distribution of supplies, equipment, and study materials to the sites.
● Re-trained site staff and management for adherence to protocol
● Regularly attends and participates in project team meetings
● Performed QA/QC on FDA regulatory documentation for protocols
Aerotek Contractor at bioMerieux 01/2013-07/2013
Clinical Scientist (Short Contract)
Therapeutic Areas: Melanoma – detection and treatment, Medical device, and IVD
Phases: III-IV
● Instrumental involvement in two (2) successful IVD product PMA approvals during contract
● Responsible for weekly meetings with the Bio partners – GSK and Novartis
● Responsible for clinical operations of site set-up, equipment, and training
● Performed CRA responsibilities for 3 protocols - IVD(invitrodiagnosticdevice) - and multiple
domestic and international sites
● Monitor and problem solve reference laboratories to ensure compliance with FDA regulations, ICH
guidelines, and GLP
● Active liaison between partnership sites and reference laboratories maintaining positive working
relationships to obtain the desired goals
● Responsible for site staff PCR (IVD BRAF) Proficiency certification and oversight
● Performed QA/QC on FDA regulatory documentation for protocols
Department ofMedicine-Hematology Duke University Medical Center 2008-2013
Clinical Research Coordinator II
Therapeutic Areas: Clotting/Bleeding disorders, Cardiothoracic surgery, HIT, Orthopedics, and GI
Phases: III
● National leader in patient recruitment in all assigned protocols
● Performed In-house monitoring duties for satellite sites (Mayo Clinic, University of Wisconsin, UNC,
and VA Hospitals) for multi-year NIH funded/sponsored cardiothoracic clinical trial
● Developed, plan, and implement clinical trial protocols with principal investigators, staff, multiple
departments, and outside vendors
● Coordinate all aspects of the clinical trial from presentations to closure of the trial
● Screen,recruit, and collect desired deliverables for protocol
● Recruitment responsibilities for institutional, industry/pharma, and federal clinical trials
● Trained various other sites and cardiology groups with enrollment strategies
● Lectured and lead break out group at severalnational PI/CRC meetings for recruitment strategies
● Performed QC/QA on assigned protocols
PRMO/Clinical Trials Duke University Health System 2006-2008
PatientAccountAnalyst
● Analyzed and performed QA/QC on all research for all DUHS centers
● Researched all aspects of an account from date to ICD9 codes
● QA accounts in Hyland Onbase from the CRSO/CTBO team
● Performed charge move transactions as necessary for compliance and completeness
● Investigate accounts and coordinate changes to accounts/clinical trial grids with CRSO/CTBO team
members and external customers
● Recorded quality and performance of CRSO/CTBO team members
● Performed. daily reports
● Trained personnel inside the clinical trial department
Operations/QC J & G Exteriors, LLC 1997-2006
Project Manager
 Developed and oversaw all proposals, contracts, accounting, and logistical methods
 Developed and maintained internal and external relationships
 Managed projects from proposal through completion
 Maintained good customer service practices and policies
 Developed and trained all personnel
 Performed QA/QC on all projects
 Analyzed and implemented policies and procedures to ensure efficiency and achievement of
company goals
Marketing and Sales Ventana Medical Systems 1993-1997
Technical Marketing Representative-Southeast Region
Therapeutic Areas: Cancer Research, Immunohistochemistry, and IVD (in vitro diagnostic
device)
Phases: I-III
• Developed, coordinated, and implemented nationwide oncology and in-situ research in Jacksonville
Memorial Women's Cancer Center,Duke University Cancer Center,NIH,Armed Forces Institute
of Pathology, University of Colorado Cancer Center,University of Arizona Medical Center, and
Cleveland Clinic.
• Developed and implemented technical and safety training for all the hospital laboratory accounts in
the Southeast region
• Responsible for QA/QC and training of staff in all of the laboratories
• Developed protocols and training to achieve all national testing accreditation (CAP,JCAHO,etc.)
• Maintained all necessary national certifications
• Organized and instructed seminars on local, regional, and national levels
Cell Imaging Lab Duke Cancer Center 1986-1993
Laboratory Technologist
Therapeutic Areas: Cancer Research, Immunohistochemistry
Phases: I-III
 Developedcancertissue bankandimplementedclinical trialsforprognostic/diagnosticmarkers
 Developed and coordinated research projects with principal investigators
 Responsible for all aspects of the immunohistochemistry laboratory
 Performed QC/QA, safety, and training for all of staff
 Analyzed, organized, and discussed data of research projects with principal investigators
 Coordinated and collaborated on the submission of manuscripts for publication
Public Safety City of Durham 1981-1986
Public Safety Officer
 ClassII NCcertifiedlawenforcementofficer
 ClassII Nationallycertifiedfirefighter
 Responsible forthe protectionandsafetyof the citizensof Durham
 Responsible forthe enforcementof the state,county,andcitylaws
 Durham traininginstructorforthe AcademyandsquadC
 CertifiedinstructorinFirearms,highriskssituation,anddefensive tactics
Education
 Candidate for Masters of Clinical Research (2017), Campbell University, Buies Creek,NC
 Bachelor of Science 1982, Business Administration/Math, Wingate College, Wingate, NC

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PJ_CV_09Jan2017

  • 1. Patrick A. Jordan 3112 Ridgestone Parkway p.l.jordan1999@gmail.com Durham, NC 27712 (C) (919)257-8983 Professional Experience  Therapeutic experience in IVD, Oncology, Hematology, Orthopedics, GI, Cardiology, Melanoma, ENT, Multiple Sclerosis, and ADHD  Extensive knowledge of FDA regulations, ICH guidelines, GLPs,GCPs, and SOPs  Monitoring experience of national and international sites for PSSVs, SIVs, IMVs,and COVs  Ability to identify issues and resolve appropriately  Experience in multiple EDC systems and platforms Professional Experience Clinical Operations Health Decisions 01/2016-07/2016 CRA Therapeutic Areas: Women’s Health – Contraceptive device, IVD, and Neonatalpreterm birth Phases: III ● Responsible forCRA dutiesforcommerciallyfundedprotocols –medical device andIVD(invitro diagnosticdevice)involvingnational sites ● Perform monitoring visits - PSSV,SIV, IMV, and COV ● Ensure the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines, and protocols ● Ensure that the rights, safety, and well-being of clinical trial subjects are maintained ● Collaborate with the Core Project Team and site staff to drive subject recruitment ● Prepare all monitoring documentation/reports for assigned protocols as required ● Establish and maintain effective contact with internal and external personnel (primary point of contact for site staff) ● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance Clinical Operations Rho, Inc. 10/2014-09/2015 CRA I Therapeutic Areas: ENT,Multiple Sclerosis, Rheumatoid Arthritis, and ADHD (Pediatrics) Phases: III ● Responsible forCRA dutiesforfederallyandcommerciallyfundedprotocolsinvolvingnational and international sites ● Performed monitoring visits - SQV,SIV, IMV, and COV ● Ensured the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines, and protocols ● Ensured that the rights, safety,and well-being of clinical trial subjects are maintained ● Collaborated with the Core Project Team and site staff to drive subject recruitment ● Prepared all monitoring documentation/reports for assigned protocols as required ● Established and maintained effective contact with internal and external personnel (primary point of contact for site staff) ● Responsible for maintaining knowledge applicable to the protocol, indication, and job performance
  • 2. DCRI Duke University Medical Center 03/2014-07/2014 CRA II Therapeutic Areas: Antibacterialresistance Phases: I-II ● Lead onPSSVsforthree (3) clinical trialsinvolving104 potential worldwide sites ● Performed site feasibility and site selection documentation for ARLG protocols ● Maintained all ARLGSite Trackers for all active and upcoming ARLG protocols ● Primary point of contact for sites and vendors ● Wrote guidelines and SOPs for ARLG protocols and international sites Ockham Contractor at Quintiles 12/2013-03/2014 CTA Therapeutic Areas: Gastrointestinal disorders Phases: III ● Lead CTA team fortwo (2) Purdue studiesas well ascontrollingaccessforall electronicsystems(EDC, CTMS, ordering,materials,andIP) forbothinternal andexternal customers ● Updated and prepared the compliance, performance,and timeline matrix ● Prepared,distributed, filed, and archived clinical documentation ● Performed QA/QC review of study files ● Distributed Clinical Trial Supplies to sites ● Controlled and maintained access for all electronic systems for internal and external customers Pinnacle Technology Contractor at BectonDickinson 07/2013-08/2013 CRA II (Short Contract) Therapeutic Areas: Women’s Health (OB/GYN) Phases: I-II ● Successfullycompletedcontractedobjective inhalf the time allotted ● Performed CRA responsibilities for 3 protocols and multiple sites ● Prepared all monitoring documentation/reports for assigned protocols as required ● Performed monitoring visits such as site evaluation, SIV, IMV, and COV ● Facilitated the distribution of supplies, equipment, and study materials to the sites. ● Re-trained site staff and management for adherence to protocol ● Regularly attends and participates in project team meetings ● Performed QA/QC on FDA regulatory documentation for protocols Aerotek Contractor at bioMerieux 01/2013-07/2013 Clinical Scientist (Short Contract) Therapeutic Areas: Melanoma – detection and treatment, Medical device, and IVD Phases: III-IV ● Instrumental involvement in two (2) successful IVD product PMA approvals during contract ● Responsible for weekly meetings with the Bio partners – GSK and Novartis ● Responsible for clinical operations of site set-up, equipment, and training ● Performed CRA responsibilities for 3 protocols - IVD(invitrodiagnosticdevice) - and multiple domestic and international sites ● Monitor and problem solve reference laboratories to ensure compliance with FDA regulations, ICH guidelines, and GLP ● Active liaison between partnership sites and reference laboratories maintaining positive working relationships to obtain the desired goals
  • 3. ● Responsible for site staff PCR (IVD BRAF) Proficiency certification and oversight ● Performed QA/QC on FDA regulatory documentation for protocols Department ofMedicine-Hematology Duke University Medical Center 2008-2013 Clinical Research Coordinator II Therapeutic Areas: Clotting/Bleeding disorders, Cardiothoracic surgery, HIT, Orthopedics, and GI Phases: III ● National leader in patient recruitment in all assigned protocols ● Performed In-house monitoring duties for satellite sites (Mayo Clinic, University of Wisconsin, UNC, and VA Hospitals) for multi-year NIH funded/sponsored cardiothoracic clinical trial ● Developed, plan, and implement clinical trial protocols with principal investigators, staff, multiple departments, and outside vendors ● Coordinate all aspects of the clinical trial from presentations to closure of the trial ● Screen,recruit, and collect desired deliverables for protocol ● Recruitment responsibilities for institutional, industry/pharma, and federal clinical trials ● Trained various other sites and cardiology groups with enrollment strategies ● Lectured and lead break out group at severalnational PI/CRC meetings for recruitment strategies ● Performed QC/QA on assigned protocols PRMO/Clinical Trials Duke University Health System 2006-2008 PatientAccountAnalyst ● Analyzed and performed QA/QC on all research for all DUHS centers ● Researched all aspects of an account from date to ICD9 codes ● QA accounts in Hyland Onbase from the CRSO/CTBO team ● Performed charge move transactions as necessary for compliance and completeness ● Investigate accounts and coordinate changes to accounts/clinical trial grids with CRSO/CTBO team members and external customers ● Recorded quality and performance of CRSO/CTBO team members ● Performed. daily reports ● Trained personnel inside the clinical trial department Operations/QC J & G Exteriors, LLC 1997-2006 Project Manager  Developed and oversaw all proposals, contracts, accounting, and logistical methods  Developed and maintained internal and external relationships  Managed projects from proposal through completion  Maintained good customer service practices and policies  Developed and trained all personnel  Performed QA/QC on all projects  Analyzed and implemented policies and procedures to ensure efficiency and achievement of company goals Marketing and Sales Ventana Medical Systems 1993-1997 Technical Marketing Representative-Southeast Region Therapeutic Areas: Cancer Research, Immunohistochemistry, and IVD (in vitro diagnostic device) Phases: I-III • Developed, coordinated, and implemented nationwide oncology and in-situ research in Jacksonville
  • 4. Memorial Women's Cancer Center,Duke University Cancer Center,NIH,Armed Forces Institute of Pathology, University of Colorado Cancer Center,University of Arizona Medical Center, and Cleveland Clinic. • Developed and implemented technical and safety training for all the hospital laboratory accounts in the Southeast region • Responsible for QA/QC and training of staff in all of the laboratories • Developed protocols and training to achieve all national testing accreditation (CAP,JCAHO,etc.) • Maintained all necessary national certifications • Organized and instructed seminars on local, regional, and national levels Cell Imaging Lab Duke Cancer Center 1986-1993 Laboratory Technologist Therapeutic Areas: Cancer Research, Immunohistochemistry Phases: I-III  Developedcancertissue bankandimplementedclinical trialsforprognostic/diagnosticmarkers  Developed and coordinated research projects with principal investigators  Responsible for all aspects of the immunohistochemistry laboratory  Performed QC/QA, safety, and training for all of staff  Analyzed, organized, and discussed data of research projects with principal investigators  Coordinated and collaborated on the submission of manuscripts for publication Public Safety City of Durham 1981-1986 Public Safety Officer  ClassII NCcertifiedlawenforcementofficer  ClassII Nationallycertifiedfirefighter  Responsible forthe protectionandsafetyof the citizensof Durham  Responsible forthe enforcementof the state,county,andcitylaws  Durham traininginstructorforthe AcademyandsquadC  CertifiedinstructorinFirearms,highriskssituation,anddefensive tactics Education  Candidate for Masters of Clinical Research (2017), Campbell University, Buies Creek,NC  Bachelor of Science 1982, Business Administration/Math, Wingate College, Wingate, NC